Remote Monitoring to Improve Low Adherence in Non-invasive Ventilation: READ-NIV Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
Patients are invited to participate in a trial to test a new way to optimise long-term use of non-invasive ventilation using remote monitoring. Breathing difficulties during sleep are frequently treated using home mechanical ventilation, also called non-invasive ventilation (NIV). Breathing difficulties during sleep affect many patients with conditions such as chronic pulmonary obstructive disease (COPD), neuromuscular conditions and obesity hypoventilation syndrome. Left untreated they can cause breathlessness, headaches, sleepiness and lead to hospitalisations and other severe adverse health outcomes.
The best available treatment for chronic types of sleep-disordered breathing is NIV. However, not every patient eligible tolerates this treatment because it requires patients to sleep with a nasal or full-face mask that is connected with a tube to a machine. Although NIV is recommended by the National Institute for Health and Clinical Excellence (NICE), many patients who should be on NIV use the treatment insufficiently within months.
Using remote monitoring to identify problems with treatment adherence early on may help to identify clinical problems, troubleshoot user- or device-dependent problems, avoid delays in treatment and safe healthcare resources in the long-term.
The investigators invite patients who use NIV to participate in this trial when they have difficulties with the treatment (NIV). This study will evaluate compliance and efficacy of a remote monitoring device (T4P device, SRETT, Paris/France) that will be connected to the standard NIV machine to remotely monitor usage. Patients will be randomly assigned to the remote monitoring using NIV for three months at home, or to usual care which is NIV without this monitoring. The primary outcome measure of this study is the improvement in adherence and compliance, as indicated by the average usage of NIV, as well as symptom scores to assess treatment effects.
详细描述
Participant Selection
Patients established on NIV for >3months will be recruited in this trial. The sample size calculation of n=32 patients is based on previous in-house data (Ishak A et al, Respirology 2019 in press) to detect a difference in the treatment arms with a Power of >80% and an alpha of 5% using the improvement adherence as an outcome parameter.
Criteria and procedures for subject withdrawal or discontinuation.
Sample size estimation assumed 15-20% of patients would not provide end of study information that could be evaluated. If this rate is observed, data for some patients will be only partially observed. For patients who withdraw or drop out before the end of the study, the "no change assumption" will be used to impute the missing subsequent values. This may introduce a bias if the main reason for drop-out was deterioration. To examine this possibility, sensitivity analysis will be performed to assess the primary efficacy outcome using different imputation methods including "best-case scenario" and "worst- case scenario" possible scores for the missing data. A second per protocol analysis, including only those subjects with complete follow-up data will also be performed.
Subject Enrolment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hypercapnic respiratory failure (PaCO2 > 6kPa)
- •low usage of home mechanical ventilation (NIV < 4hours/night).
- •body mass index (BMI) >18.5kg/m2
- •all genders
- •age 18-90years.
排除标准
- •no hypercapnic respiratory failure (PaCO2<6kPa)
- •no sleep-disordered breathing (AHI<5/hour)
- •exclusively obstructive sleep apnoea
- •isolated Rapid-Eye-Movement (REM) sleep associated OSA
- •cachexia (BMI <18.5 kg/m2)
- •severe pulmonary hypertension
- •valvular heart disease
- •heart failure (New York Heart Association, NYHA III-IV)
- •myocardial infarction and significant cardiac arrhythmias
- •uncontrolled hypertension
- •active psychiatric disease
- •co-existing non-respiratory sleep disorder.
结局指标
主要结局
Adherence
时间窗: 3 months
Usage / night (hours)
次要结局
- SpO2(3 months)
- Hospital Anxiety and Depression Scale(3 months)
- Healthcare Resource Usage(3 months)
- Severe Respiratory Insufficiency Questionnaire(3 months)
- Arterial Blood Gas analysis(3 months)
- EQ-5D(3 months)
- Epworth Sleepiness Scale(3 months)
- Stanford Sleepiness Scale(3 months)
